Intervention type

Phase

Drug names

Primary outcome measures

To establish that the study is safe, well tolerated and patient acceptable.

Patients wil be asked to complete validated questionaires (Mood Rating Scale, Hospital Anxiety and Depression Scale, Patient Attitude to Treatment Scale, FACT-Biological Response Modifiers) prior to treatment, at each vaccination visit and 4 weeks after the final vaccination. The forms will be evaluated and statistically analysed by Chi square and Fisher's exact tests at the end of treatment.

Morbidity, side effects of treatment, will be documented at each clinic visit. Serious adverse events (SAEs) and sudden unexpected serious adverse reactions (SSUSARs) will be documented if and when they occur.

Secondary outcome measures

The generation of specific anticancer immunological responses and objective evidence of clinical responses during the programme.

Blood will be taken for assessment of immunological parameters prior to treatment, at each vaccination visit and 4 weeks after the end of treatment. Tumour markers, if present, will also be monitored at each visit and documented.

Reduction or stasis of tumour volume will be recorded at each visit if there is measureable tumour.